Kornimate/medical-research-clean huggingface dataset:
take heed (healthy eating and exercise decisions)

Conditions: Obesity

Summary: this is a randomized intervention that examines the effect of culturally adapted weight loss program in african american (aa) females age 40-65. evidence suggests that aa women are more successful with weight loss programs that are culturally tailored (karanja, et al, 2002). take heed is a combination of 2 interventions, therapeutic lifestyle changes diet (tlc) from atp-iii and the change exercise program, which have shown success independently in previous clinical trials with aas.

project/study objective(s), this is a randomized intervention that examines the effect of culturally adapted weight loss program in african american (aa) females age 40-65. evidence suggests that aa women are more successful with weight loss programs that are culturally tailored (karanja, et al, 2002). take heed is a combination of 2 interventions, therapeutic lifestyle changes diet (tlc) from atp-iii and the change exercise program, which have shown success independently in previous clinical trials with aas. methods, the 21 month program (6 months active intervention and 15 months maintenance) is provided by a nurse matched with the study participants for race, age, and gender. take heed uses behavior change strategies (prochaska et al 1992) which have been modified to include spirituality, aa cultural materials and examples woven into the lesson plans, and sustained peer support. the diet has been modified to include calorie reductions, increased fruit/ vegetable and calcium intake, incorporation of aa ethnic recipes. exercise has been culturally adapted featuring line- dancing, brisk walking and includes socialization time for development of strong interpersonal bonds that will encourage exercise in the participants. the control group receives kp's usual care which is a combination of nutrition classes and web based learning.

Eligibility criteria:
inclusion criteria: * bmi greater than 30 * african american * 40-46 years old exclusion criteria: - bariatric surgery within the previous 5 years

Keywords: obesity behavior change cultural adaptations weight loss
efficacy and safety study of allogenic mesenchymal stem cells for patients with refractory primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: the study is designed to evaluate the safety and efficacy of intravenous administration of bone marrow derived mesenchymal stem cells for patients with refractory primary biliary cirrhosis (pbc).

primary biliary cirrhosis (pbc) is an organ-specific inflammatory disease and characterized by immune mediated destruction of intrahepatic bile ducts, then lead to liver cirrhosis and eventually failure.currently, ursodeoxycholic acid (udca) is the only drug approved by the food and drug administration (fda). novel treatment is urgently needed for patients who have an incomplete response to udca. mesenchymal stem cells (msc) represent a promising tool for cell-based therapies of autoimmune diseases. to explore the therapeutic effect of mscs for pbc, the investigators plan to conduct an open-label, randomized clinical trial. patients with pbc will be enrolled and randomly divided into two groups which will receive mscs and udca respectively. the investigators will evaluate the efficacy and safety of mscs for pbc by comparison of symptom improvement, survival rate and side effects in the two groups.

Eligibility criteria:
inclusion criteria: * there must be at least two of the following: a concentration in serum of amas at titres of 1:40 or higher; an unexplained rise in the amount of alkaline phosphatase of at least 1•5 times the upper limit of normal for more than 24 weeks; and compatible liver histological findings, specifically non-suppurative cholangitis and interlobular bile duct injury. * incomplete response to udca at 13-15 mg/kg/day, criteria for the group of complete responders is including: concentrations of alkaline phosphatase less than three times the upper limit of normal, aspartate aminotransferase less than twice the upper limit of normal, and bilirubin less than 17 μmol/l;and normalisation of abnormal concentrations of bilirubin, albumin, or both. * liver pathological staging in 2 or3, histological staging is based on ludwig's and scheuer's classifications exclusion criteria: * patients are receiving any other investigational agents within 4 weeks of study entry * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive cmv viremia), symptomatic congestive heart failure (nyh class iii and iv), unstable angina pectoris, or cardiac arrhythmia * in pregnancy or lactation * psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible * hcvpositive ，hbsag positive or with other liver diseases * combined with other autoimmune disease * expected survival time is less than one year * decompensation of liver function（child b or c） * have a history of allergy or allergic constitution

Keywords: biliary cirrhosis
prospective phase ii study of intraoperative radiotherapy (iort) in elderly patients with small breast cancer

Conditions: Breast Neoplasms; Breast Diseases; Neoplasm Recurrence, Local; Neoplasms

Summary: this prospective, multicentric single arm phase ii study is based on the protocol of the international targit-a study. the purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, ct1, cn0, cm0, invasive-ductal) which is followed by wbrt only when risk factors are present. in presence of risk factors postoperative wbrt will be added to complete the radiotherapeutic treatment according to international guidelines.

patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 4% after 4 years. with adjuvant whole breast radiotherapy (wbrt) the local relapse rate drops to 1% after 4 years under tamoxifen (hughes et al 2004). it has been demonstrated (polgar et al. 2007, vaidya et al. 2010) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to wbrt. the targit e study should confirm the efficacy of a single dose of intraoperative radiotherapy (iort) in a well selected group of elderly patients with small breast cancer and absence of risk factors. in presence of risk factors postoperative wbrt will be added to complete the radiotherapeutic treatment according to international guidelines. endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome. the expected local relapse rates are 0.5/1/1.5% after 2.5/5/7.5 years, respectively. discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6% after 2.5/5/7.5 years. power calculations result in 265 patients with a calculated loss to follow-up of 20%, an alpha of 0.05 and a beta 0.1. only centers with access to the intrabeam® system (carl zeiss) can recruit patients into the trial.

Eligibility criteria:
inclusion criteria: * ct1c cn0 cm0 * ≥ 70 years old * invasive-ductal histology * compliance * informed consent exclusion criteria: * extensive intraductal component (eic) * multifocality /-centricity * lymph vessel invasion (l1) * clinical signs of distant metastases or clinically suspicious lymph nodes * other histology * \< 70 years old * missing informed consent or non-compliance * bilateral breast cancer at time of diagnosis * known braca 1/2 mutations (genetic testing not required)

Keywords: keywords provided by university hospital mannheim: intraoperative radiotherapy early breast cancer elderly patients
conventional biopsies vs pcle for diagnosis of superficial gastric neoplasia

Conditions: Early Gastric Cancer; Gastric Dysplasia

Summary: confocal endomicroscopy (cle) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. previous studies have investigated the accuracy of pcle for diagnosis and differentiated of colorectal polyps, barrett's esophagus and pancreaticobiliary strictures. however, to date there are limited data exploring the application of pcle to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pcle using the final specimens obtained from endoscopic resection as a reference standard. the aims of this study were (1) the accuracy of pcle compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pcle diagnosis with that of blinded "off-line" pcle diagnosis, and off-line interobserver agreement.


Eligibility criteria:
inclusion criteria: * patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection. exclusion criteria: * patients with uncorrectable coagulopathy, * liver cirrhosis, * acute gastrointestinal bleeding, * pregnancy, * breast feeding, * documented allergy to fluorescein, * patients with lesions that were deemed unsuitable for endoscopic resection, and * patients without documented conventional biopsy results.
repeatability and reproducibility of cirrus hd-oct measurements of illumination areas under the retinal pigment epithelium

Conditions: Advanced Dry AMD With Geographic Atrophy

Summary: the objective of this study is to determine the repeatability and reproducibility of the cirrus hd-oct measurement of illumination areas under the retinal pigment epithelium (rpe).

this is a prospective, single site study. ocular history and examination will be conducted on consented subjects to determine further participation in the study. the study will be divided into two phases. in phase 1, the inter-device variability of cirrus hd-oct measurements of illumination areas under the rpe will be determined. in phase 2, the inter-operator variability of cirrus hd-oct measurements of illumination areas under the rpe will be determined. in each of these phases, the macular cube 200 x 200 scan and the macular cube 512 x 128 scan will be evaluated.

Eligibility criteria:
inclusion criteria: * males or females 50 years of age and older diagnosed to have advanced dry amd with geographic atrophy. * geographic atrophy lesions should: * not be greater than 5 mm at the widest diameter. the entire lesion(s) should fit into the 6x6 mm scan area of the cirrus hd-oct. * not be smaller than 1.25 mm2. * not be confluent with peri-papillary atrophy. * not be combined with other lesions such as cnv. * able and willing to make the required study visits. * able and willing to give consent and follow study instructions. exclusion criteria: * history of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. * evidence of other retinal diseases of the eye, including wet amd, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction. * thick media opacity or inability to fixate that precludes obtaining acceptable scans. * concomitant use of hydrochloroquine or chloroquine. * unable to make the required study visits. * unable to give consent or follow study instructions.
artificial intelligence-based emergency triage education tool in enhancing clinical critical thinking and triage practice

Conditions: Nursing Teaching Pedagogy; Conversational AI Nursing Education Serious Game

Summary: the study aims to develop an artificial intelligence (ai) based emergency triage education tool for providing critical thinking and questioning skills training to nursing students. it also aims to contribute valuable implications by collecting the knowledge, attitudes, and compassion aspects of nursing students toward ai-based education the objectives of the study: 1. to evaluate the effectiveness of instructor-led and self-play pedagogy approaches in enhancing students' critical thinking by an ai-based emergency triage education tool. 2. to evaluate the effectiveness of instructor-led and self-play pedagogy approaches in enhancing students' triage skill retention by an ai-based emergency triage education tool. 3. to evaluate students' learning motivation, simulation-based experience, and usability towards ai-based technology learning. participants will 1. play the education tool in different pedagogy approaches 2. answer the questionnaires and receive a qualitative interview


Eligibility criteria:
inclusion criteria: 1. aged 18 or above; 2. currently studying the nurs 225f of the bachelor of nursing (general) at hong kong metropolitan university; 3. able to use electronic devices to accomplish an online survey and participate in the ai-based emergency triage education tool exclusion criteria: * currently working in emergency department
long term follow-up of hiv infected patients who have previously participated in hiv clinical trials

Conditions: HIV Infections

Summary: the purpose of this study is to monitor the progression of hiv infection and hiv-related disease processes in patients who have previously participated in hiv clinical trials.

since 1982, the national institute of allergy and infectious diseases (niaid) has been conducting numerous clinical trials on patients infected with hiv-1. unfortunately, once clinical studies have closed or participants have reached a study endpoint, no additional follow-up data are collected regarding progression of hiv infection and development of hiv-related complications in these study participants. this study will collect long-term data for participants of previous niaid-sponsored clinical trials to study hiv-related disease processes and complications, benefits and toxicities of investigational medications and vaccines, and medical management of participants with known or suspected hiv infection. study visits will occur every 6 months. a physical exam, blood collection, and medical history will occur at all visits. depending on the need of participants, additional laboratory and diagnostic tests will be performed, and standard medical care will be provided.

Eligibility criteria:
inclusion criteria: * hiv infected * previously participated in a niaid-funded clinical trial studying hiv disease
effectiveness of decision-aid video on colorectal cancer screening

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is the second most common cancer in malaysia. diagnosing crc at early stage is crucial to reduce their mortality risk. to achieve this aim, crc screening promotion intervention is deemed necessary.

high-quality crc screening interventions and approaches should be delivered to a large proportion of target population. to our knowledge, there is no interactive video been developed, that can be used as educational tool for crc screening in malaysia. by developing an educational video, we hope that it can be used by health professionals to promote crc screening, favoring their empowerment for prevention and control of disease.

Eligibility criteria:
inclusion criteria: * malaysian aged 50 - 74 years old * no previous history or family history of crc * asymptomatic of crc * never participated in crc screening exclusion criteria: * acute patients * patients on aspirin, warfarin or any blood-thinning agent * illiterate or having a significant vision or hearing impairment

Keywords: screening primary care video
restricted convalescence: outcomes following urogynecologic procedures

Conditions: Pelvic Organ Prolapse

Summary: the investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. we hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.

pelvic floor disorders (pfd) dramatically affect millions of women's quality of life (qol), and 30% of american women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life. surgical goals of women with pfd is often to resume their normal activities, which they have limited secondary to bothersome symptoms. yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions. activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process. we aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted). women having surgery for pfd will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, qol and anatomic outcomes will be measured after surgery. we hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and qol, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions. these data will change paradigms of women's health and recovery after surgery.

Eligibility criteria:
inclusion criteria: * ambulatory women undergoing surgical management of pelvic organ prolapse * prolapse \> to stage ii on pop-q * age \>18 yrs * completed childbearing * all subjects must have given signed, informed consent prior to registration on study * all subjects must be able to read and complete study documents exclusion criteria: * wheelchair-bound women * women with neurologic disease (multiple sclerosis, parkinson's disease) * abdominal approach with laparotomy

Keywords: pelvic organ prolapse reconstructive pelvic surgery postoperative restrictions patient satisfaction
study of the immune response after vaccination in multiple myeloma patients

Conditions: Multiple Myeloma; Myeloma, Multiple; Myeloma-Multiple

Summary: this study will collect blood samples from healthy volunteers and volunteers with multiple myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae b (hib), and/or meningococcus vaccines. the main goal of the study is to start to identify differences in the immune response between multiple myeloma patients and people who don't have multiple myeloma. we hope this will provide important information about the best way and time to vaccinate multiple myeloma patients to flu, pneumonia, haemophilus influenzae b (hib), and/or meningococcus .

this study will consist of a prospective blood sample collection to gather baseline data to confirm antibody protection from vaccines in the aurora health care multiple myeloma (mm) patients. the overall goal of this study is to obtain a normative dataset for mm patients and non-mm control populations as well as determining baseline igg levels to seasonal influenza a, influenza b, pneumococcal polysaccharide, and tetanus toxoid and confirmation of antibody protection from vaccines with assays based upon who standards of detection. this is part of a series of studies designed to provide important information about the best way and time to vaccinate mm patients to flu, pneumonia, haemophilus influenzae b (hib), and/or meningococcus and to gather additional information about mm and immune function.

Eligibility criteria:
inclusion criteria: * 50 years old or over * planning on getting the seasonal flu and/or pneumonia vaccine as part of normal care * have multiple myeloma, or don't have multiple myeloma and want to serve as a health control exclusion criteria: - do not meet inclusion criteria

Keywords: influenza pneumococcal pneumonia vaccine immunization #caimmun immuno-oncology supportive care vaccination meningococcal hib
postoperative vitamin supplementation in morbidly obese patient (vitaal study)

Conditions: Obesity; Vitamin Deficiency

Summary: this study is a double blind randomized controlled trial.

based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and roux-en-y gastric bypass (rygb). these preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin b12 and vitamin d can be reduced.

Eligibility criteria:
inclusion criteria: * patients on the waiting list for rygb or gastric band and meets * age between 18-65 years exclusion criteria: 1. creatinine \> 150micromol / l 2. liver enzymes \> 2 times the upper limit 3. previous surgery on the gastrointestinal tract 4. intercurrerence disease 5. gastrointestinal diseases 6. psychiatric illness 7. drugs that affect bone metabolism 8. known pregnancy

Keywords: vitamine mineral obese patients vitamine en mineral shortage in obese patients
diagnostic accuracy of shuntcheck compared to radionuclide shunt: patency in patients with normal pressure hydrocephalus

Conditions: Hydrocephalus, Normal Pressure

Summary: the purpose of this study is to assess the diagnostic accuracy of shuntcheck compared with radionuclide shunt patency testing (sps) to detect csf shunt flow of nph patients with suspected shunt obstruction.

the purpose of this study is to assess the diagnostic accuracy of shuntcheck compared with radionuclide shunt patency testing (sps) to detect csf shunt flow of nph patients with suspected shunt obstruction.

Eligibility criteria:
inclusion criteria: * men or women 40 yo or older and have a vp shunt placed for nph and are suspected of shunt obstruction. * capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent exclusion criteria: * presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; * shuntcheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; * presence of an interfering open wound or edema over any portion of the vp shunt.

Keywords: asymptomatic normal pressure hydrocephalus ventriculoperitoneal shunt